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New treatment option for Congenital Syphilis
Official title Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
ClinicalTrials.gov ID: NCT07189208
What this study is testing
What is Benzathine penicillin 2.4 million units?
Benzathine penicillin 2.4 million units is an investigational medicine, given as a monthly injection into a muscle, being studied as a potential treatment for congenital syphilis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if benzathine penicillin works to prevent maternal syphilis. It will also learn about the safety of benzathine penicillin.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Uncomplicated, viable pregnancy
- Elevated risk for syphilis acquisition (one or more of the following):
- Prior history of STIs last 3 years
- HIV infection
- Age \< 21 years
You likely can't join if
- Non-viable pregnancy
- Very high risk pregnancy
- Inability to provide written informed consent
- Allergy to penicillin
- Positive rapid treponemal test at baseline
- Lack of sexual activity during study period.
See the full eligibility criteria
- Uncomplicated, viable pregnancy
- Elevated risk for syphilis acquisition (one or more of the following):
- Prior history of STIs last 3 years
- HIV infection
- Age \< 21 years
- In a sexual partnership of \ 3 sexual partners in the last 6 mo.
- Late initiation of prenatal care (\> 14 weeks of pregnancy)
- Residence in area where syphilis prevalence is 10% or higher.
- Ability to provide written informed consent
- No allergy to penicillin
- Prenatal care at one of the sites participating in the study
- Ongoing sexual activity during study period.
- Negative rapid treponemal test at baseline.
- Non-viable pregnancy
- Very high risk pregnancy
- Inability to provide written informed consent
- Allergy to penicillin
- Positive rapid treponemal test at baseline
- Lack of sexual activity during study period.
- Any persisting coagulation disorder that would contraindicate IM injections.
The study team makes the final eligibility decision.
Where it's taking place
- Duque de Caxias, Rio de Janeiro, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duque de Caxias, Rio de Janeiro, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.